BEUDAMED
    FDA Recall Terminated

    Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).

    Recall: Z-0629-03 · Initiated February 4, 2003

    Recall

    Recall Number
    Z-0629-03
    Event Number
    25587
    Firm
    Biomerieux, Inc.
    FEI Number
    1039284
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 4, 2003
    Posted
    March 6, 2003
    Terminated
    January 21, 2004
    Address
    100 Rodolphe Street, Durham, NC, 27712

    Description

    Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).

    Reason

    Product is being recalled due to vial to vial variability of clotting time results.

    Action

    Consignees were notified by a Customer Notification letter sent via regular mail on/about February 4, 2003 with response form attached. An additional cover letter was sent to international affiliates/distributors who were responsible for notifying their customers. Consignees were asked to report the amount of product on hand and to destroy the product. On March 18th the firm expanded the recall. Consignees were notified by letter on March 19th , and March 31, 2003 and were advised to stop using the affected lot numbers, destroy the remaining material in inventory and to contact their local bioMerieux Customer Service representative for replacement.

    Distribution

    Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela

    Quantity

    62,435 units, Expanded Lot #161659, 3525 boxes; 161660, 1489 boxes; 161711, 3990 boxes